Manager, Clinical Data Management

Responsibilities

• Own data management study deliverables end-to-end from data capture tool development through database lock
• Represent DM as the functional lead at study team meetings
• Oversee DM study deliverables including quality, adherence to Study Plans, and SOPs
• Perform data reconciliation for vendors and SAEs
• Investigate and remediate reviewer-reported data issues
• Coordinate with CROs and third-party vendors for DM startup timelines and EDC modifications
• Develop and maintain DM project documentation including CRFs, Data Management Plans, and Data Review Plans
• Ensure quality checks for statistical review and manage database lock and close-out activities

Requirements

• Undergraduate degree
• 4-6 years of industry experience
• Knowledge of global standards for clinical data management
• Proficiency in Microsoft Office and web-based applications
• Strong project management and organizational skills
• Excellent attention to detail and communication skills

About the Company

ProKidney is a biotechnology company focused on advancing clinical programs through high-quality data management and innovative cell therapies.